Clinical Evaluation Procedure Bundle
The Clinical Evaluation Procedure Bundle includes procedures for Clinical Evaluation, Clinical Investigation, Post Market Surveillance, and CE Marking.
- MDR EU 2017/745 Compliant
- ISO 14155:2011 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MEDDEV 2.12.2
- MEDDEV 2.7.1
- MS Word Format
- Instant Download Digital Content
Clinical Evaluation Procedure Bundle
The Clinical Evaluation Procedure Bundle includes (4) procedures relating to CE Marking. MEDDEV 2.7.1 Rev 4, MEDDEV 2.12.1, ISO 14155:2011, MDR 2017/745 and ISO 13485:2016 compliant. The Clinical Evaluation Procedure Bundle is intended for the following:
Clinical Evaluation Procedure Bundle Overview
The Clinical Evaluation Procedure Bundle covers clinical evaluation, clinical investigation, post market surveillance, and the CE Marking of medical devices. The procedures within the clinical evaluation bundle are used to generate supportive documentation required for CE marking and pre-market approvals.
The Clinical Evaluation Procedures define the process to plan, conduct and generate a substantive Clinical Evaluation Report (CER) , a Clinical Investigation Plan (CIP), Post Market Surveillance (PMS), including requirements for Post-Market Clinical Follow-up (PMCF). We also include a CE Marking Procedure providing guidance on technical file construct and medical device classification.
Clinical Evaluation Procedure Bundle Contents
The Clinical Evaluation Procedure Bundle includes the following procedures:
Clinical Evaluation Procedure Bundle Compliance
The Clinical Evaluation Procedure Bundle is MEDDEV 2.7.1 Rev 4, MEDDEV 2.12.1, ISO 14155:2011, MDR 2017/745 and ISO 13485:2016 compliant.
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Clinical Evaluation Procedures
Clinical evaluation, clinical investigation, post market surveillance, and CE Marking procedures. MEDDEV 2.7.1, MEDDEV 2.12.1, ISO 14155, MDR 2017/745 compliant. The Clinical Evaluation Procedure Bundle includes the following procedures:
Clinical Evaluation Procedure
The clinical evaluation procedure defines the process to plan, continuously conduct and document a clinical evaluation and defined requirements for post-market clinical follow-up. The procedure provides detailed instruction on: defining the scope of a clinical evaluation; identification of pertinent data and literature reviews; appraisal of pertinent data; analysis of clinical data; and generating the clinical evaluation report (CER) including an instructive CER report template with guidance for each section. The procedure also provides detailed instruction on post market clinical follow-up (PMCF).
Clinical Investigation Procedure
The clinical investigation procedure defines the process to conduct European clinical investigations in accordance with Medical Device Regulation (EU) 2017/745, MEDDEV 2.7/1 and ISO 14155:2011. The procedure provides detailed instruction for clinical investigation planning, development and content of a clinical investigation plan (CIP), sponsor obligations, and detailed instruction on how to generate a clinical investigation report.
Post Market Surveillance Procedure
The post market surveillance (PMS) procedure governs the process to establish, implement and update a post market surveillance system. The procedure applies to all medical devices produced by the company requiring post market surveillance as part of compliance with applicable standards and regulations and company policy. The procedure provides detailed instruction on types of knowledge and feedback, sources of PMS information, establishing a post market surveillance plan for each device, generation of a post market surveillance report and periodic safety update report (PSUR). The procedure includes an easy to follow example of a post market surveillance plan.
CE Marking Procedure
The CE Marking procedure ensures all medical devices that are to be commercialized in the European Economic Area are in compliance with the European Medical Device Regulation (MDR) EU 2017/745. The procedure includes detailed instruction on initial device evaluation, construct of technical file / design dossier, proper handling of design changes, conformity assessment routes, Notified Body notification process, declaration of conformity and post market activity.